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Ledipasvir | CAS No: 1256388-51-8 | GMP-certified suppliers
A medication that, combined with sofosbuvir, treats chronic hepatitis C virus infections across multiple genotypes, including patients with cirrhosis and those co-infected with HIV.
Therapeutic categories
Primary indications
- When used in combination with the antiviral medication [sofosbuvir], ledipasvir is indicated for the treatment of treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older with the following conditions:
- Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
- Genotype 1 infection with decompensated cirrhosis, in combination with [ribavirin]
- Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with [ribavirin]
Product Snapshot
- Ledipasvir is an oral small molecule antiviral available in multiple solid dosage forms including tablets and granules
- It is primarily indicated for the treatment of chronic hepatitis C virus (HCV) infections across multiple genotypes, including in special populations such as liver transplant recipients and patients co-infected with HIV
- Ledipasvir is approved for use in major regulatory markets including the US, Canada, and the European Union
Clinical Overview
Clinically, ledipasvir is indicated for use in combination with sofosbuvir for the treatment of HCV genotypes 1, 4, 5, and 6 in adults and pediatric patients aged three years and older. It is effective in patients both with and without cirrhosis, and with ribavirin for certain cases such as genotype 1 infection with decompensated cirrhosis or liver transplant recipients. The combination regimen aims to achieve a sustained virologic response (SVR) after 12 weeks of daily oral therapy, which is considered a virological cure. This therapeutic approach is associated with significant long-term clinical benefits including reduced liver damage, decreased risk of hepatocellular carcinoma, and lower all-cause mortality.
Pharmacokinetic data indicate that ledipasvir has minimal impact on the QT interval at doses exceeding the recommended therapeutic level. The drug is classified as a fluorenes derivative and exhibits inhibitory activity against various HCV genotypes, notably genotypes 1a, 1b, 4a, and 5a, with reduced efficacy against genotypes 2a and 3a. Ledipasvir also possesses a high barrier to resistance relative to other antivirals targeting HCV protease enzymes.
Safety profiles from clinical use demonstrate that ledipasvir, particularly in the approved fixed-dose combination with sofosbuvir (marketed as Harvoni), is generally well tolerated. The most commonly reported adverse effects are headache and fatigue, which are comparatively mild versus older interferon- and ribavirin-based therapies.
From a sourcing and quality perspective, procurement of ledipasvir API should prioritize compliance with current Good Manufacturing Practices and regulatory standards. Verification of identity, purity, and consistent potency is critical, given the compound’s role in life-saving antiviral regimens. Additionally, stability under recommended storage conditions and freedom from contaminants influence the overall suitability of ledipasvir for pharmaceutical formulation.
Identification & chemistry
| Generic name | Ledipasvir |
|---|---|
| Molecule type | Small molecule |
| CAS | 1256388-51-8 |
| UNII | 013TE6E4WV |
| DrugBank ID | DB09027 |
Pharmacology
| Summary | Ledipasvir is a direct-acting antiviral agent targeting the Hepatitis C Virus (HCV) nonstructural protein 5A (NS5A), which is essential for viral RNA replication and virion assembly. Its mechanism involves inhibition of NS5A hyperphosphorylation, disrupting viral production. Ledipasvir is utilized in combination therapies for the treatment of chronic HCV infection across multiple genotypes and patient populations. |
|---|---|
| Mechanism of action | Ledipasvir is an inhibitor of the Hepatitis C Virus (HCV) NS5A protein required for viral RNA replication and assembly of HCV virions. Although its exact mechanism of action is unknown, it is postulated to prevent hyperphosphorylation of NS5A which is required for viral production. |
| Pharmacodynamics | Ledipasvir acts against HCV and is categorized as a direct-acting antiviral agent (DAA). At a dose of 120 mg twice daily (2.67 times the maximum recommended dosage), ledipasvir does not prolong QTc interval to any clinically relevant extent. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Nonstructural protein 5A | Hepatitis C Virus | inhibitor |
ADME / PK
| Absorption | When given orally, ledipasvir reaches its maximum plasma concentration in about 4 to 4.5 hours with a maximum concentration (Cmax) of 323 ng/mL. |
|---|---|
| Half-life | The median terminal half-life of ledipasvir is 47 hours. |
| Protein binding | Ledipasvir is >99.8% bound to human plasma proteins. |
| Metabolism | In vitro, no detectable metabolism of ledipasvir was observed by human CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Evidence of slow oxidative metabolism via an unknown mechanism has been observed. Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively to the parent drug (>98%). Unchanged ledipasvir is the major species present in feces. |
| Route of elimination | Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in feces and urine was approximately 87%, with most of the radioactive dose recovered from feces (approximately 86%). Unchanged ledipasvir excreted in feces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose. These data indicate that biliary excretion of unchanged ledipasvir is a major route of elimination, with renal excretion being a minor pathway (approximately 1%). |
Formulation & handling
- Ledipasvir is a small molecule API intended for oral administration in various solid dosage forms such as tablets and granules.
- It exhibits very low water solubility and high lipophilicity (LogP 7.18), which may require formulation strategies to enhance bioavailability.
- Administration timing relative to antacids and avoidance of inducers like St. John's Wort should be considered due to potential impacts on drug absorption and serum levels.
Regulatory status
| Lifecycle | The API is currently under patent protection in the United States until 2028-2030, with existing market presence in the US, Canada, and the EU. Its lifecycle is in a mature phase with ongoing exclusivity limiting generic competition primarily in the US market. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Ledipasvir is characterized by a limited number of originator companies producing branded products primarily under the Harvoni name across the US, Canada, and EU markets. Multiple US patents protecting Ledipasvir extend through 2028 to 2030, indicating that patent exclusivity is currently maintained, with generic competition likely to emerge post-patent expiry. This suggests a controlled branded market presence with generic entrants anticipated in the medium term. |
|---|
Safety
| Toxicity | There is very little toxicity associated with the use of ledipasvir in combination products. The most common adverse reactions are headache and fatigue. |
|---|
- Minimal systemic toxicity observed with ledipasvir
- Primary adverse reactions include headache and fatigue
- Handle with appropriate protective measures to avoid inhalation or dermal exposure due to limited safety data on chronic occupational exposure
Ledipasvir is a type of HCV polymerase inhibitors
HCV polymerase inhibitors are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) used in the treatment of Hepatitis C virus (HCV) infections. These inhibitors target the RNA-dependent RNA polymerase (NS5B) enzyme, which plays a crucial role in the replication of the HCV virus within human cells.
By specifically inhibiting NS5B, these pharmaceutical compounds effectively hinder viral replication, reducing viral load and helping to control the progression of HCV infection. HCV polymerase inhibitors are commonly used in combination with other antiviral agents, such as direct-acting antivirals (DAAs), to achieve optimal therapeutic outcomes.
One of the key advantages of HCV polymerase inhibitors is their high potency and specificity against the NS5B enzyme, which minimizes the risk of off-target effects and increases the likelihood of successful treatment. Moreover, these inhibitors have shown excellent efficacy against a broad range of HCV genotypes, making them suitable for patients with diverse viral strains.
Researchers and pharmaceutical companies continue to innovate and develop new HCV polymerase inhibitors with enhanced efficacy and improved safety profiles. Ongoing efforts in this field aim to expand treatment options, reduce treatment durations, and improve the overall cure rates for patients infected with HCV.
In conclusion, HCV polymerase inhibitors are essential components of modern antiviral therapy for Hepatitis C. Their targeted inhibition of the NS5B enzyme demonstrates significant clinical benefits, providing patients with more effective and personalized treatment options, ultimately improving their quality of life.
Ledipasvir (HCV polymerase inhibitors), classified under Anti-infective Agents
Anti-infective agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various infectious diseases. These agents play a crucial role in combating bacterial, viral, fungal, and parasitic infections. The demand for effective anti-infective APIs has grown significantly due to the increasing prevalence of drug-resistant microorganisms.
Anti-infective APIs encompass a wide range of substances, including antibiotics, antivirals, antifungals, and antiparasitics. Antibiotics are particularly important in fighting bacterial infections and are further categorized into different classes based on their mode of action and target bacteria. Antivirals are designed to inhibit viral replication and are essential in the treatment of viral infections such as influenza and HIV. Antifungals combat fungal infections, while antiparasitics are used to eliminate parasites that cause diseases like malaria and helminthiasis.
The development and production of high-quality anti-infective APIs require stringent manufacturing processes and adherence to regulatory standards. Pharmaceutical companies invest heavily in research and development to discover new and more effective anti-infective agents. Additionally, ensuring the safety, efficacy, and stability of these APIs is of utmost importance.
The global market for anti-infective APIs is driven by factors such as the rising incidence of infectious diseases, the emergence of new and drug-resistant pathogens, and the growing demand for improved healthcare infrastructure. Continuous advancements in pharmaceutical technology and the development of innovative drug delivery systems further contribute to the expansion of this market.
In conclusion, anti-infective agents are a critical category of pharmaceutical APIs that play a pivotal role in treating infectious diseases. Their effectiveness in combating various types of infections makes them essential components in the arsenal of modern medicine.
Ledipasvir API manufacturers & distributors
Compare qualified Ledipasvir API suppliers worldwide. We currently have 8 companies offering Ledipasvir API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 229 products |
| Dalian Wista Pharma Co Lt... | Producer | China | China | CoA | 16 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
| Natco Pharma | Producer | India | India | CoA, GMP, WC | 40 products |
| PCAS | Producer | France | France | CoA, GMP | 29 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 157 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
When sending a request, specify which Ledipasvir API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Ledipasvir API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
